Back to resultsSutures in Orbital Implants in Retinoblastoma Patients
Primary Purpose
Surgery--Complications, Retinoblastoma Bilateral
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
5-0 suture
4-0 suture
Sponsored by
About this trial
This is an interventional treatment trial for Surgery--Complications focused on measuring Retinoblastoma, suture, complications
Eligibility Criteria
Inclusion Criteria:
- diagnosed as retinoblastoma
- enucleation and orbital implantation in the same surgery
Exclusion Criteria:
- death during follow-up
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
5-0 suture
4-0 suture
Arm Description
5-0 suture administration during surgery
4-0 suture administration during surgery
Outcomes
Primary Outcome Measures
Rate of participants with complications
complications, such as orbital implant exposure in the follow-up visit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04383860
Brief Title
Sutures in Orbital Implants in Retinoblastoma Patients
Official Title
Choice of Sutures in Orbital Implants in Retinoblastoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.
Detailed Description
To evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery--Complications, Retinoblastoma Bilateral
Keywords
Retinoblastoma, suture, complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5-0 suture
Arm Type
Experimental
Arm Description
5-0 suture administration during surgery
Arm Title
4-0 suture
Arm Type
Active Comparator
Arm Description
4-0 suture administration during surgery
Intervention Type
Procedure
Intervention Name(s)
5-0 suture
Other Intervention Name(s)
5-0 suture administration
Intervention Description
5-0 suture administration during surgery
Intervention Type
Procedure
Intervention Name(s)
4-0 suture
Other Intervention Name(s)
4-0 suture administration
Intervention Description
4-0 suture administration during surgery
Primary Outcome Measure Information:
Title
Rate of participants with complications
Description
complications, such as orbital implant exposure in the follow-up visit
Time Frame
2 year after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed as retinoblastoma
enucleation and orbital implantation in the same surgery
Exclusion Criteria:
death during follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huijing Ye
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sutures in Orbital Implants in Retinoblastoma Patients
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